Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, how NICE (a) classifies and (b) regulates new treatments made up of a combination of active substances.

The National Institute for Health and Care Excellence does not classify or regulate new treatments. Licensing of new medicines, including combinations of active substances, is undertaken by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicine Agency in consultation with the MHRA. The MHRA is the Government agency responsible for ensuring that medicines and medical devices work and are acceptably safe.

Most combinations of active substances are so-called ‘fixed combinations’ – most commonly a tablet containing two or more different medicines. Fixed combination applications can be classified as:

- Products containing one or more new active substances;

- Products containing a combination of previously licenced substances; and

- Generic copies of the above.

The legal basis for the regulation of combination medicinal products is given in European Union Directive 2001/83/EC as amended, and subsequently implemented into United Kingdom medicines legislation. The specific legal basis and the data requirements for combination medicinal products vary depending on the active substances in the combination, the development undertaken, and the licenced indications of the product.